Clinical Trial: Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS

Brief Summary: This randomized clinical trial studies home-based HPV or clinic-based Pap screening for cervical cancer. It is not yet known whether home-based screening is more effective, cost-effective, and/or acceptable than clinic-based screening for cervical cancer.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Compare the sensitivity and specificity for cervical intraepithelial neoplasia (CIN) of two screening approaches:

  • Novel approach: every 3 years high risk-human papillomavirus (HR-HPV) testing of (at home) self-collected samples with in-clinic cytology of HR-HPV positive women and referral to colposcopy of women with cytology > atypical squamous cells of uncertain significance (ASCUS); repeat HPV testing of HR-HPV positive but cytology negative women at one year;
  • Currently recommended approach: for women < 30: every 3 years in-clinic cytology screening, with HPV based triage of women with ASCUS and referral to colposcopy of all women with squamous intraepithelial lesion (SIL) and/or HPV+ ASCUS; for women 30+, screening by Papanicolaou (Pap) and HPV, every 2-3 year (depending on previous history) with referral to colposcopy of those who are HPV 16/18+ or with cytology > ASCUS; retesting of those who are positive for other HR-HPV at one year.

II. Compare these two approaches with respect to overall cost-effectiveness and acceptability.

III. Determine the performance and cost-effectiveness of each approach in vaccinated and unvaccinated women < 30.

OUTLINE: Participants are randomized to 1 of 2 arms.

GROUP I (home-based HPV screening): Participants collect 2 vaginal specimens using polyester swabs. Participants with a positive HPV test result will have a Pap test. Participants with an abnormal Pap test will undergo standard of care as in Group II.

GROUP II (clinic-based stan
Sponsor: University of Washington

Current Primary Outcome:

  • Cost-effectiveness in the novel approach in vaccinated and unvaccinated women less than 30 years old [ Time Frame: Up to 4 years ]
  • Cost-effectiveness in the standard approach in vaccinated and unvaccinated women less than 30 years old [ Time Frame: Up to 4 years ]
  • Overall cost-effectiveness and acceptability [ Time Frame: Up to 4 years ]
    The results from the trial (sensitivity, specificity, and costs) will be used in conjunction with a Markov model to determine cost per LY and cost per QALY. Model outcomes (per 100,000 screened) will include the expected numbers of false-positive test results, colposcopies, cases of CIN 1+, cases of cancer, cancer deaths, life expectancy and quality adjusted life-expectancy. Strategies will be compared using incremental cost-effectiveness ratios. Costs and outcomes will be discounted at 3% annually. One, 2-way and probabilistic sensitivity analyses conducted for all inputs to the models.
  • Sensitivity and specificity for CIN 1+ of currently recommended in-clinic cytology screening [ Time Frame: Up to 4 years ]
    An intention-to-treat analysis, based upon the initial randomization, will be performed to evaluate differences between study arms (screening strategies). Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies using standard methodologies.
  • Sensitivity and specificity for CIN 1+ of novel home-based testing [ Time Frame: Up to 4 years ]
    An intention-to-treat analysis, based upon the initial randomization, will be performed t

    Original Primary Outcome:

    • Sensitivity and specificity of self-collected at home human papillomavirus test with reflex cytology [ Time Frame: 5 Years ]
      Compare whether cervical cancer screening of self-collected at home human papillomavirus test with reflex cytology is as effective as the currently recommended approach of cytology with reflex human papillomavirus testing.
    • Total estimated costs associated with cervical cancer screening [ Time Frame: 5 Years ]
      Compare novel and standard care approaches with respect to over all cost-effectiveness (direct and in-direct costs)
    • Patient satisfaction with self-collected at home human papillomavirus test screening as measured by study questionnaires [ Time Frame: 5 Years ]
      Compare novel and standard care approaches acceptability to patients


    Current Secondary Outcome:

    Original Secondary Outcome:

    • Sensitivity and specificity of self-collected at home human papillomavirus test with reflex cytology in human papillomavirus vaccinated and unvaccinated women less than 30 years old [ Time Frame: 5 Years ]
      Compare novel and standard care arm performance in human papillomavirus vaccinated and unvaccinated women less than 30 years old
    • Sensitivity and specificity of human papillomavirus DNA genotyping and detection of aberrantly DNA methylated genes for referring high risk human papillomavirus positive women to colposcopy to identify cervical intraepithelial neoplasia 2,3+ [ Time Frame: 5 Years ]
      In the novel arm, determine the potential utility of triage of high risk human papillomavirus positive women to colposcopy for identification of cervical intraepithelial neoplasia 2,3+ based on human papillomavirus DNA genotyping or detection of aberrantly DNA methylated genes
    • Total estimated costs associated with cervical cancer screening in human papillomavirus vaccinated and unvaccinated women less than 30 years old [ Time Frame: 5 Years ]
      Compare novel and standard care arm cost-effectiveness in human papillomavirus vaccinated and unvaccinated women less than 30 years old


    Information By: University of Washington

    Dates:
    Date Received: February 17, 2012
    Date Started: March 2012
    Date Completion:
    Last Updated: January 23, 2017
    Last Verified: January 2017